All forms of hormonal contraception increase a woman's risk of breast cancer—and that's also true for the 'safer' progesterone-only pill, a major new study has found.They increase the risk by around 20 per cent on average, and some risk was still there even five years after stopping.Women who have taken a hormone contraceptive—and this also includes non-oral devices such as the hormone-intrauterine system (IUS)—for a year or less have a 9 per cent raised risk, and the risk rose to 38 per cent among those who've used hormone contraception for more than 10 years.Researchers from the University of Copenhagen tracked the health of 1.8 million women for nearly 11 years. During that time, 11,517 women developed breast cancer, and the researchers noted that those who were taking some form of hormonal contraceptive were more likely to do so than those who weren't using the contraceptives. The risk was just as evident among women who were taking the supposedly safer progesterone-only contraceptive.Overall, the contraceptive was responsible for one extra case of breast cancer for every 7,690 women taking it for at least a year, and there would be one additional case for every 1,500 women taking the pill for five years or longer.The one piece of good news was that the risk was relative and not absolute. That means that other factors could have played a part in the women getting the cancer—such as diet or pollution—and it couldn't be established that only the pill was responsible

The Lancet paper by Shang et al.In August 2005, the Lancet published a study1 which was reported as having compared 110 similar trials on homeopathy and conventional medicine, and reached the conclusion that homeopathy is no better than placebo.An accompanying editorial by The Lancet editor entitled ‘The end of homoeopathy’2 lead to widespread media attention.However, the conclusions of this study were in fact based on only 8 of the 110 trials, none of which involved usual homeopathic care. Furthermore, if you switch just one of the 8 trials they picked from the 110 for a different one, the results are reversed, showing that homeopathy works beyond placebo.3This demonstrates that the findings of this paper are completely unreliable.The sequence of events surrounding this issue of The Lancet, the political controversy which followed and key flaws of the study itself, are summarised in ‘Homeopathy and the Lancet‘.3A paper with continued global impactThe Shang et al. paper has become notorious because, despite such fundamental flaws, it continues to be mis-quoted to this day as definitive ‘proof’ that homeopathy doesn’t work e.g.:“Over 150 trials have failed to show it works”Dr Ellie Cannon – resident GP for the Mail on Sunday. ‘Health Comment’, Mail on Sunday, 14 September 2014

“We’ve had over 100 trials of homeopathy now. For any medical treatment, after 100 trials have failed to give good overall evidence of benefit, this is the point at which a sensible person, with no vested interests in that one particular treatment, would loudly and clearly state: “No more money should be spent researching this blind alley”.Ben Goldacre – British physician, academic and science writer.‘Pharma Chameleon’, New Europe, 17 April 2011 – Issue 93.Results of the Shang paperShang et al.’s findings as reported in the abstract of the paper are:110 homoeopathy trials and 110 matched conventional-medicine trials were analysed. The median study size was 65 participants (range ten to 1573). 21 homoeopathy trials (19%) and nine (8%) conventional-medicine trials were of higher quality. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials. When the analysis was restricted to large trials of higher quality, the odds ratio was 0·88 (95% CI 0·65–1·19) for homoeopathy (eight trials) and 0·58 (0·39–0·85) for conventional medicine (six trials).Note: These ‘odds ratios’ mean that, for these particular 8 trials of homeopathy, if you analyse them together, the results suggest that the effects seen are due to placebo rather than a real clinical effect.How reliable are these results?The role of the Shang paper in the homeopathy debate cannot be overstated, so the issue of quality and reliability of the paper is paramount.Unfortunately, the poor scientific quality of the paper is obvious, having been described by experts in the field of homeopathy research3,4,5,6,7 as well as independent researcher Prof Hahn, who highlights the main problem:To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be disregarded.8

MoreRelevance of Shang’s 2005 paper in 2015Reliability of the analysis is not the only problem with the Shang paper. As we take a fresh look at the evidence in 2015, we also need to consider how well this study reflects the entirety of today’s evidence base.A rigorous study by Mathie et al. published in 2014, found that homeopathic medicines, when prescribed during individualised treatment, are 1.5- to 2.0-times more likely to have a beneficial effect than placebo.13This study includes 151 placebo-controlled randomised trials – 41 more than Shang’s team identified in 2005, but which would have met their inclusion criteria if they had been available at the time.This demonstrates the extent to which the 10 year-old Shang et al. paper, which now covers only 73% of the eligible trials, has been superseded.Read HRI’s brief summary of Mathie et al.’s study or listen to Robert Mathie presenting his findings at the HRI Rome 2015 conference.Shang et al. key facts

Although 110 homoeopathy trials and 110 matched conventional medicine trials were included in the study, the results were based on only 8 homeopathy trials and 6 conventional medicine trials described as ‘larger higher quality trials’.

If all 21 homeopathy trials they identified as higher quality had been analysed, they would have got the opposite result – that homeopathy has an effect beyond placebo.10 No justification has been given for discounting the other 13 high quality trials just because they were smaller.

The study fails a ‘sensitivity analysis’ i.e. if you switch just one of the 8 homeopathy trials they chose from the 110, you get the opposite result i.e. that homeopathy works better than placebo.4

None of the 8 homeopathy trials they used involved individualised homeopathic treatment – the form of homeopathy considered to be ‘usual care’ – instead they were testing non-individualised homeopathic medicines given without a consultation. The conclusions of this study therefore have no relevance to the evidence base ‘for or against’ usual homeopathic treatment.

The 8 trials used were testing a range of different homeopathic medicines being used for different conditions. One would assume that, as with conventional medicine, some homeopathic treatments work and others don’t, so it is no surprise that some of these studies were negative whilst others were positive. Mixing the results together to decide whether they show ‘homeopathy’ works makes no scientific sense.

In the original paper Shang et al. do not state which 8 homeopathy trials and which 6 conventional trials they used. Such lack of reporting transparency and precision is typically not tolerated in studies of conventional medicine.6 Following an outcry, the authors eventually provided this information.

The decade-old Shang paper is out of date and has been superseded. Since 2005, 41 more placebo-controlled randomised trials have been published which would have been suitable for inclusion in Shang’s review. These have been included in the most recent meta-analysis by Mathie et al. published in 2014 which reached a positive conclusion.13

The Australian reportIn March 2015, the Australian National Health and Medical Research Council (NHMRC) published an Information Paper on homeopathy, commonly referred to as ‘The Australian Report’.1This document concludes that “…there are no health conditions for which there is reliable evidence that homeopathy is effective”.This report triggered headlines around the world suggesting NHMRC had found that homeopathy doesn’t work for any condition.3Australian Report key factsAn extensive detailed investigation by Gerry Dendrinos of the Australian Homeopathic Association (AHA) into NHMRC’s conduct, combined with an in-depth scientific analysis of the report by HRI, revealed evidence of serious procedural and scientific misconduct in producing this report:

NHMRC did the homeopathy review twice, producing two reports, one in July 2012 and the one released to the public in March 2015.

The existence of the first report has never been disclosed to the public – it was only discovered by AHA through Freedom of Information (FOI) requests.

NHMRC say they rejected the first report because it was poor quality despite it being undertaken by a reputable scientist and author of NHMRC’s own guidelines on how to conduct evidence reviews.

FOI requests have revealed that a member of NHMRC’s expert committee overseeing the review process – Professor Fred Mendelsohn – confirmed the first review to be high quality saying, “I am impressed by the rigor, thoroughness and systematic approach given to this evaluation of the published reviews of efficacy and side effects of homeopathy [….] Overall, a lot of excellent work has gone into this review and the results are presented in a systematic, unbiased and convincing manner.”

NHMRC said the results of the report published in 2015 were based on a “rigorous assessment of over 1800 studies”. In fact results were based on only 176 studies.

NHMRC used a method that has never been used in any other review, before or since. NHMRC decided that for trials to be ‘reliable’ they had to have at least 150 participants and reach an unusually high threshold for quality. This is despite the fact that NHMRC itself routinely conducts studies with less than 150 participants.

These unprecedented and arbitrary rules meant the results of 171 of the trials were completely disregarded as being ‘unreliable’ leavingonly 5 trials NHMRC considered to be ‘reliable’. As they assessed all 5 of these trials as negative, this explains how NHMRC could conclude that there was no ‘reliable’ evidence.

Professor Peter Brooks, Chair of the NHMRC committee that conducted the 2015 review, initially failed to declare that he was a member of the anti-homeopathy lobby group ‘Friends of Science in Medicine’.

In violation of NHMRC’s own guidelines there was not one homeopathy expert on the committee.

Complaint submitted to Commonwealth OmbudsmanIn August 2016 HRI’s in-depth scientific analysis was used as part of a submission of complaint to the Commonwealth Ombudsman brought by Complementary Medicines Australia, Australian Homoeopathic Association and Australian Traditional Medicine Society.Download the Executive Summary of the Ombudsman submissionhere.

Rachel Roberts, Chief Executive of HRI says “NHMRC’s review is just bad science. Decision-makers and the scientific community rely on these kinds of reports and need to trust their accuracy. This is not about anyone’s personal opinion as to whether homeopathy works or not. It is about the importance of evidence being reported objectively, whatever it says, and the NHMRC did not do that.”As the complaint is ongoing, our full analysis – some 60 pages – cannot be shared as yet, but HRI’s data provided details demonstrating the following scientific failures by NHMRC which necessitate retraction of the Australian Report:

Evidence that this was a case of deliberate bias, not scientific error.

Dr Alex Tournier, Executive Director of HRI, explains: “The inaccuracies in NHMRC’s report are so extreme that we decided to work with the AHA to conduct a thorough investigation to fully uncover exactly what went on.”The complainants are now waiting to hear back from the Ombudsman regarding their submission. As NHMRC’s inaccurate Homeopathy Review has had a significant impact on the field of homeopathy research worldwide, HRI will share any news regarding the complaint as the case progresses.Roberts says: “The public has a right to know that there are high quality studies showing homeopathy works for some medical conditions, such as hay fever, sinusitis and diarrhoea in children – information that was lost only due to NHMRC’s mishandling of the evidence. If the evidence on conventional medicine was treated this way there would be an outcry – and rightly so. NHMRC’s job was to accurately summarise the body of evidence for homeopathy for the public, a task in which they categorically failed.”The missing first reportNHMRC’s investigation into Homeopathy ran from 2010 to 2015. NHMRC initially worked with an external contractor – from April 2012-August 2012 – to produce a review of the evidence on Homeopathy to inform the Australian public.The report produced was called ‘A Systematic Review of the Evidence on the Effectiveness of Homeopathy’.This review, paid for by Australian tax payers, was never made public and NHMRC continue to refuse to release it, despite repeated Freedom of Information requests.After terminating the contract with the first review team, a second external contractor – OptumInsight – was hired to do the Homeopathy review again from December 2012-March 2015.HRI is not alone in criticising the accuracy of NHMRC’s findingsFOI requests have brought to light that two independent experts also raised concerns over the conclusions of the 2015 report during peer review, prior to final publication. The Australasian Cochrane Centre commented that for some conditions, “…. ‘no reliable evidence’ does not seem an accurate reflection of the body of evidence”; a second expert felt “uncertain of the definitive nature of the Report’s conclusions”. NHMRC chose not to act on this feedback and did not amend their conclusions.The real story behind the headlinesThe Information Paper is designed for the general public and aims to provide a summary of the findings of a review of systematic reviews, carried out by NHMRC to assess the evidence base for effectiveness of homeopathy in humans.2Confusing ‘lack of evidence of effect’ with ‘evidence of a lack of effect’The Report’s conclusion that there is ‘no reliable evidence’ that homeopathy works, has been widely misunderstood, with people believing it meant that the NHMRC found that homeopathy does not work for the conditions tested, which would be a completely different result.This misunderstanding triggered widespread media coverage, propagating the inaccurate story that the NHMRC found homeopathy to be no better than placebo for all the conditions.In fact, NHMRC concluded that homeopathy worked no better than placebo for only 13 of the 61 health conditions they investigated.HRI’s in-depth scientific analysis of the Australian Report revealed multiple examples of bias and misreporting which explain how NHMRC arrived at such a definitive and negative position, at odds with the conclusions of the majority of other more academically rigorous systematic reviews and meta-analyses on homeopathy.Most crucially, NHMRC’s findings hinge primarily on their definition of reliable evidence: for a trial to be deemed ‘reliable’ it had to have at least 150 participants and a quality score of 5/5 on the Jadad scale (or equivalent on other scales). Trials that failed to meet either of these criteria were dismissed as being of ‘insufficient quality and/or size to warrant further consideration of their findings’.Setting such a high quality threshold is very unusual, but the N=150 minimum sample size criterion isarbitrary, without scientific justification, and unprecedented in evidence reviews.Out of 176 individual studies the NHMRC included in the homeopathy review, only 5 trials met their definition of ‘reliable‘, none of which, according to their analysis, demonstrated effectiveness of homeopathy. This explains why NHMRC concluded there is ‘no reliable evidence’ that homeopathy is effective.For context it is worth remembering that if it was indeed the case that ‘no reliable evidence’ existed for homeopathy, it would put homeopathy in the same evidence category (“unknown effectiveness”) as 46% of conventional treatments used in the NHS, but in fact this conclusion is inaccurate.Contrary to NHMRC’s findings, there are ‘good quality, well-designed studies with enough participants for a meaningful result‘ (to use NHMRC’s description of a reliable study) which show that certain homeopathic treatments are effective for certain conditions such as hay fever, sinusitis, upper respiratory tract infections, diarrhoea in children and lower back pain. The fact that the results of such studies were unjustifiably dismissed means that NHMRC have misled the public by misreporting the evidence for effectiveness of homeopathy.Find out more on our Australian Report FAQs pagehttps://www.hri-research.org/resources/homeopathy-the-debate/the-australian-report-on-homeopathy/

WW.FACULTYOFHOMEOPATHY.ORG/RESEARCHThe Research Evidence Base for HomeopathySystematic reviews of randomised controlled trials (RCTs) of homeopathy• Two major reviews of RCTs of individualised homeopathyhave reached broadly positive conclusions.

• Four of ­five major comprehensive reviews of RCTs in homeopathy have reached broadly positive conclusions.Only Based on a smaller selection of trials, a ­fth review came to a negative conclusion about homeopathy.

• Positive conclusions have been reported in 9 of 35 reviews of RCTs in speci­c categories of medical condition (the other 26 are largely inconclusive): •allergies and upper respiratory tract infections

•childhood diarrhoea

•post-operative ileus

•rheumatic diseases

•seasonal allergic rhinitis

•vertigo

Placebo-controlled RCTs of homeopathy - the original data

Up to the end of 2014, the peer-reviewed literature included 153 papers reporting placebo-controlled RCTs, of which 104 have data eligible for our analysis: 43 positive;5 negative; 56 not statistically conclusive. In addition to the medical conditions above, there is a positive balance of evidence in the following, for example: •influenza

•insomnia

•sinusitis

There is evidence from singleton placebo-controlled RCTs in favour of homeopathy for a number of other conditions including: - bronchitis,